A comparative observational study to evaluate the safety and effectiveness of Xromi® (hydroxycarbamide oral solution 100mg/ml) for the prevention of vaso-occlusive complications of sickle cell disease in children under 2 years of age. [PRECISE PASS]

16/12/2024
21/01/2026
EU PAS number:
EUPAS1000000076
Study
Ongoing
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Documents
Study protocol
Initial protocol

CONFIDENTIAL_NOVDD-001_ Xromi PRECISE PASS_ Protocol_V2.0_18Oct2024_Unsigned_Redacted_Published.pdf

English (3.8 MB - PDF) View document
Updated protocol

CONFIDENTIAL_NOVDD-001_ Xromi PRECISE PASS_ Protocol_V3.0_05Aug2025_FE_Redacted.pdf

First published: 19/01/2026
English (6.49 MB - PDF) View document
Study results
Study report
Other information